U.S. patent number 7,480,387 [Application Number 11/502,053] was granted by the patent office on 2009-01-20 for in the ear hearing aid utilizing annular acoustic seals.
Invention is credited to John A. Meyer, Dean Thomas Penman.
United States Patent |
7,480,387 |
Meyer , et al. |
January 20, 2009 |
In the ear hearing aid utilizing annular acoustic seals
Abstract
Disclosed is a hearing aid assembly wherein the hearing aid is
comprised of an acoustic receiver, an acoustic transmitter, and a
body, and an annular channel, wherein the acoustic receiver is
designed to fit into a external acoustic meatus of an ear, the
acoustic transmitter is designed to fit into a inner ear canal, and
the generally cylindrical body is disposed between the receiver and
the transmitter, the annular channel is disposed on the surface of
the body such that it circumscribes the body's circumference. The
annular channel is adapted to receive an annular ring which
functions as an acoustic seal and which, in one preferred
embodiment, has a T-shaped cross-section.
Inventors: |
Meyer; John A. (Rochester,
NY), Penman; Dean Thomas (Clarence, NY) |
Family
ID: |
39082659 |
Appl.
No.: |
11/502,053 |
Filed: |
August 10, 2006 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20070009129 A1 |
Jan 11, 2007 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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10992040 |
Nov 18, 2004 |
7164775 |
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60525911 |
Dec 1, 2003 |
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Current U.S.
Class: |
381/322; 381/328;
381/324 |
Current CPC
Class: |
H04R
25/652 (20130101); B33Y 70/00 (20141201); B33Y
80/00 (20141201); H04R 25/658 (20130101); H04R
2225/023 (20130101); H04R 2225/77 (20130101); H04R
2460/15 (20130101) |
Current International
Class: |
H04R
25/02 (20060101) |
Field of
Search: |
;381/322,324,328
;181/129,130,134,135 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
International Search Report and Written Opinion of the
International Searching Authority, Jul. 26, 2006 (9 pages). cited
by other.
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Primary Examiner: Ensey; Brian
Attorney, Agent or Firm: Greenwald; Howard J
Parent Case Text
CROSS-REFERENCE TO RELATED PATENT APPLICATIONS
This application is a continuation-in-part of applicants' patent
application Ser. No. 10/992,040, filed on Nov. 18, 2004 now U.S.
Pat. No. 7,164,775, which claims the benefit of U.S. Ser. No.
60/525,911, filed on Dec. 1, 2003. The entire content of each of
the aforementioned applications is hereby incorporated by reference
into this specification.
Claims
We claim:
1. A hearing aid assembly comprising a hearing aid wherein said
hearing aid is comprised of an acoustic receiver, an acoustic
transmitter, a body, a first annular channel, a first annular ring
with a cross-sectional T shape, wherein: (a) said acoustic receiver
is operatively configured to fit into an external acoustic meatus
of an ear, (b) said acoustic transmitter is operatively configured
to fit into an inner ear canal of said ear, (c) said body is
disposed between said acoustic receiver and said acoustic
transmitter, said body being generally elliptical, (d) said first
annular channel is disposed on a surface of said body such that
said first annular channel circumscribes said body's circumference,
(e) said first annular ring is disposed within said first annular
channel, (f) said first annular channel has a first death which is
less than a depth of said first annular ring, such that said first
annular ring protrudes from said first annular channel, (g) the
quotient of a depth of said first annular channel divided by a
thickness of said first annular ring is less than about 0.85, (h)
said body further comprises first cavity and a second cavity, each
of which extends through a surface of said body, (i) said first
annular ring comprises a noncircular cross section with at least
five sides, and (j) said annular ring has a Shore A hardness of
from about 12 to about 14.
2. The hearing aid assembly as recited in claim 1, wherein said
annular ring has an elongation of from about 50 to about 90
percent.
3. The hearing aid assembly as recited in claim 2, wherein said
body is further comprised of a second annular channel wherein said
channel circumscribes said body.
4. The hearing aid assembly as recited in claim 3, wherein said
first annular ring has a four lobed quad cross section.
5. A hearing aid assembly comprising a hearing aid wherein said
hearing aid is comprised of an acoustic receiver, an acoustic
transmitter, a body, a first annular channel, and a first annular
ring with a cross-sectional T shape, wherein: (a) said acoustic
receiver is operatively configured to fit into an external acoustic
meatus of an ear, (b) said acoustic transmitter is operatively
configured to fit into an inner ear canal of said ear, (c) said
body is disposed between said acoustic receiver and said acoustic
transmitter, said body being generally elliptical, (d) said first
annular channel is disposed on a surface of said body such that
said first annular channel circumscribes said body's circumference,
(e) said first annular ring is disposed within said first annular
channel, (f) said first annular channel has a first depth which is
less than a depth of said first annular ring, such that said first
annular ring protrudes from said first annular channel, (g) the
quotient of a depth of said first annular channel divided by a
thickness of said first annular ring is less than about 0.85, (h)
said first annular ring comprises a first cross section wherein
said first cross section comprises a noncircular cross section with
at least five sides, (i) said first annular channel comprises an
annular channel cross section, first annular ring comprises a first
indented portion, wherein said annular channel cross section
comprises a shape that engages said first indented portion of said
first annular ring, and (j) said first annular ring has a Shore A
hardness of from about 12 to about 14.
6. The hearing aid assembly as recited in claim 5, wherein said
first annular ring has an elongation of from about 50 to about 90
percent.
Description
FIELD OF THE INVENTION
A hearing aid assembly with a housing whose outer surface contains
one or more annular channels within which are disposed a compliant
acoustic material ring seal that preferably has a cross-sectional
shape similar to that of T.
BACKGROUND OF THE INVENTION
Hearing aid assemblies are well known to those skilled in the art.
By way of illustration and not limitation, reference may be had to
U.S. Pat. No. 6,228,020 (compliant hearing aid), U.S. Pat. No.
6,438,244 (hearing aid construction with electronic components
encapsulated in soft polymeric body), U.S. Pat. No. 6,473,512
(apparatus and method for a custom, soft-solid hearing aid), U.S.
Pat. No. 6,434,248 (soft hearing aid molding apparatus), U.S. Pat.
No. 6,432,247 (method of manufacturing a soft hearing aid), the
references cited during the prosecution of the aforementioned
United States patents, and the like. The entire disclosure of each
of these United States patents, and of each of the references cited
during their prosecution, is hereby incorporated by reference into
this specification. Some of the teachings of these "prior art"
patents are discussed below.
Major strides have been made in the hearing aid industry in the
programmable digital signal processing systems. Hearing care
professionals expected these advancements to solve the problematic
issues of traditional sound amplification and thus advance the
market forward. Unfortunately, these expectations have not been
fully realized. These developments have solved many of the problems
associated with traditional electronic design.
Historically, custom molded ear worn hearing instruments have been
limited to an "acrylic pour" process as the means of construction.
The development of computer chip microminiaturization and the
development of computer chip programming, the ear worn instruments
have become smaller.
Developments outside the hearing aid industry have resulted in a
more advanced level of microminiaturization of electronic
components for industrial applications. Thus, advanced signal
processing can be housed in less volume than was necessary for the
traditional electroacoustic components.
With the development of programmable hearing aids, using either
analog or digital signal processing, custom electronic design has
shifted from the manufacturing level to the clinical level. The
hearing care professionals can now customize the acoustic system
response using software control.
Advances have also been made in the custom prosthetic design and
manufacture. In the late 1960's custom in the ear hearing aids were
developed. The materials and techniques were adopted from the
dental industry. The housing or shell is constructed with an
acrylic ester copolymer that is hard. The shell housing hardness
indexes or resistance to deformation is in the range of 90 Shore D
scale. This is very hard. By comparison, a bowling ball has a
hardness of about 90 Shore D scale. This process provides a
structure that possesses the required strength and stiffness
necessary to protect the sensitive electronic components mounted
within the shell. Acrylic shells of in the canal hearing aids are
positioned near the bony portion of the ear canal.
Digital production of customized hearing aids today replaces the
labor intensive process with one that is fully computer driven. The
hearing aids produced with this system typically offer a
significantly better fit and therefore better performance than
hearing aids produced using the techniques adopted from the dental
industry.
The ear impression scanner is the point of entry of the digital
hearing aid production system. The patient's ear impression is
scanned using an optical scanning system. Laser planes are
projected onto the ear impression. High-resolution cameras acquire
images of the lines thus created on the ear impression. Image
processing software tracks the images of the lines thus created on
the ear impression.
The initial output of the scanning process is a point surface of
approximately 200,000 points that is dependant on the impression.
Surface creation software then optimizes this data and creates a
polygonal model. The final surface is reduced to approximately
25,000 triangles. This results in an accurate replica of the full
original impression in a compressed format, which makes it easy to
manipulate, store and transfer.
Software creates a user defined shell thickness and optimally
positions the electronic module, transducers and any controls. The
ventilation and sound exit are then created. A milling path for the
faceplate ensures a correct fit with the shell's geometry. Once the
shell has been completed, it can be visualized inside the original
impression to assess the fit with the user's ear. Deviations
between the original impression and the finished shell can be
displayed. The completed shell date is then imported to the 3D
printing equipment. The printers use stereo lithography that uses a
laser to solidify thin layers of a hypoallergenic UV cured acrylic
liquid polymer. The shell is manufactured by the 3D printer.
The bony portion of the canal is extremely sensitive and intolerant
of shells that are over sized or is in contact with the canal wall
beyond the second anatomical bend. The rigid shell that does not
compress pivots in reaction to jaw or head movement. This changes
the direction of the receiver and transmitter yielding distorted
acoustic response. In addition, the pivot action causes
displacement of the device resulting in unwanted acoustic feedback.
This problem has caused many shell modifications, thereby
compromising the precision approach design process. Many such
devices require some modification by the manufacturer. Most
manufacturers can expect a high percentage of returns for
modifications or repair within the first year. Thus, completely in
the canal shell design has been reduced to more of a craft than
science.
The current trend for custom hearing aid placement is to position
the instrument toward the bony portion of the ear canal. The ear
canal can be defined as the area extending from the concha to the
tympanic membrane. It is important to note that the structure of
this canal consists of elastic cartilage laterally, and porous bone
medially. The cartilaginous portion constitutes the outer one third
of the ear canal. The medial two-thirds of the ear canal is osseous
or bony. The skin on the osseous canal, measuring only about 0.2 mm
in thickness, is much thinner than that of the cartilaginous canal,
which is 0.5 mm in thickness. The difference in thickness directly
corresponds to the presence of apocrine (ceruminous) and sebaceous
glands found only in the fibro-cartilaginous area of the canal.
Thus, this thin-skinned thinly lined area of the bony canal is
extremely sensitive to any hard foreign body, such as a hard shell
hearing instrument.
Exacerbating the issue of placement of a hard foreign body into the
osseous area of the canal is the ear canal's dynamic nature. It is
geometrically altered by temporomandibular joint action and changes
in head position. This causes an elliptical type of elongation
(widening) of the ear canal. These alterations in canal shape vary
widely from person to person. Canal motion makes it very difficult
to achieve a comfortable, true acoustic seal with hard shell
material. When the instrument is displaced by mandibular motion, a
leakage or slit leak creates an open loop between the receiver and
the microphone and relates directly to an electroacoustic
distortion commonly known as feed back. Peripheral acoustic leakage
is a complex resonator made up of many transient resonant cavities.
These cavities are transient because they change with jaw motion as
a function of time, resulting in impedance changes in the ear
canal.
These transients compromise the electroacoustic performance of the
hearing aid. The properties of the hard shells have limitations
that require modification to the shell exterior to accommodate
anatomical variants and the dynamic nature of the ear canal. The
shell must be buffed and polished until comfort is acceptable. The
peripheral acoustic leakage caused by these modifications results
in acoustic feedback before sufficient amplification is
attained.
Hollow shells used in today's hearing aid designs create internal
or mechanical feedback pathways unique to each device. The
resulting feedback requires electronic modifications to "tweak" the
product to a compromised performance. With the industry's efforts
to facilitate the fine tuning of the hearing instruments for
desired acoustic performance, programmable devices were developed.
The intent was to reduce the degree of compromise, but by their
improved frequency spectrum the incidence of feedback was
heightened. As a result, the industry still falls well short of
audiological optimum.
A few manufacturers have attempted all soft, hollow shells as
alternatives to the hard hollow shells. Unfortunately, soft vinyl
materials shrink, discolor, and harden after a relatively short
period of wear. Polyurethane has proven to provide a better
acoustic seal than polyvinyl, but has an even shorter wear life.
Silicones have long wear life but are difficult to bond with
plastics such as acrylic, a necessary process for the construction
of the custom hearing instruments. To date, acrylic has proven to
be the only material with long term structural integrity. The fact
remains, that the entire ear is a dynamic acoustic environment and
is ill-served by a rigid material.
There are manufacturers constructing solid soft hearing
instruments. The material is very soft, comprising an elastomer of
about 3 to 55 durometer Shore A, and preferable 10 to 35 Shore A.
The material can be a silicone polymer and it actually encapsulates
the electronic components. This compliant type of hearing aid body
solves many of the problems noted with the hard shell bodies.
Unfortunately, fundamental electronic mounting problems result. The
basic issue is the constant flexing of all of the very fine
diameter interconnection wires from the micro miniature chip to the
receiver, transmitter and face plate. The potential consequences
are wire breakage and micro chip bond failure. The main cause of
this constant flexing is the ear canal's dynamic nature. It is
geometrically altered by temporomandibular joint action and changes
in hear position. The electronic components are encapsulated and
thus are forced to move with the soft body of the hearing aid. The
result is a loss of reliability of the complex computer controlled
system. The interconnection system must not be constantly flexed.
The problem is further complicated by the necessary flexing
whenever the instrument is inserted or removed from the patient's
ear. The reliability of the bond between the soft silicone polymer
and face plate is also questionable. The net result is a complex
system that solves many of the problems associated with hard shell
instruments but suffers from reliable system operation.
It is an object of this invention to provide a hearing aid assembly
that is superior to the prior art hearing aid assemblies. By way of
illustration and not limitation, some of the more particular
objects of the invention are described below.
It is an object of this invention to provide an assembly that
improves the performance and reliability of the hard shell acrylic
ester copolymer hearing aid instruments or similar material and the
solid soft hearing instruments. This is provided by incorporation
of many of the unique advantages of both the hard shell and solid
soft shell hearing aid instruments.
It is an object of this invention to provide a hearing aid assembly
with one or more of the improved functions described below.
In one embodiment, a hypoallergenic UV cured acrylic shell hearing
aid body (or similar material) is used, but the hearing aid body
geometry for the right and left ear is modified by computer
modeling to remove any portion of the shell that would interfere
with the ear canal that is geometrically altered by the patients'
temporomandibular joint action and changes in head position
In another embodiment, a hypoallergenic UV cured acrylic shell
hearing aid body (or similar material) is used, but the hearing aid
body geometry for the right and left ear is modified by computer
modeling to add two acoustic seal ring channels. The first channel
is positioned near the receiver and face plate and the second near
the transmitter. The channel depth is a fixed distance from the ear
canal following the contour of the ear canal at the exact location
of the acoustic seal ring. The location of the channels is
determined for each ear and selected in the area where the ear
canal geometry movement due to the patient's temporomandibular
joint action and change in head position is minimal.
In yet another embodiment, one or more compliant acoustic solid
material ring seals are used; these comprise an elastomer of about
3 to 55 durometer (Shore A); and they position the hard hearing aid
body at the center of the ear canal and along the acoustic axis of
the ear canal. This results in improved acoustic response as
distortion resulting from transmitter and receiver movement is
minimized.
In yet another embodiment, one or more compliant acoustic solid
material ring seals are used, comprising an elastomer of about 3 to
55 durometer (Shore A) that provides acoustic sealing near the
transmitter and the other near the receiver and face plate. This
prevents acoustic feedback. This is a direct result of removing any
portion of the shell that would interfere with the ear canal that
is geometrically altered by the patient's temporomandibular joint
action and changes in head position.
In yet another embodiment, one or more compliant acoustic solid
material ring seals are used, comprising an elastomer of about 3 to
55 durometer (Shore A); these seals provide stable positioning of
the receiver and transmitter in the ear canal, thus minimizing
distorted acoustic response due to mandibular motion.
In yet another embodiment, one or more compliant acoustic solid
material ring seals, comprising an elastomer of about 3 to 55
durometer (Shore A) provide true acoustic sealing and allow more
acoustic power directed at the tympanic membrane without acoustic
feedback.
In another embodiment, one or more compliant acoustic solid
material ring seals, comprising an elastomer of about 3 to 55
durometer (Shore A), allow positioning of the transmitter in the
sensitive bony portion of the ear canal. This greatly improves the
acoustic performance of the hearing aid instrument.
In another embodiment, one or more compliant acoustic solid
material ring seals, comprising an elastomer of about 3 to 55
durometer Shore A, allow positioning the transmitter near the
sensitive bony portion of the ear canal. In some cases it is not
possible to position the hearing aid instrument in the bony portion
of the patient's ear canal.
In another embodiment, one or more compliant acoustic solid
material ring seals, comprising an elastomer of about 3 to 55
durometer (Shore A), each have a different Shore A durometer. The
acoustic ring seal near the face plate and the receiver have either
a higher or lower Shore A durometer than the acoustic ring seal
near the transmitter deep in the canal. The system can thus be
finely tuned to the patient's special requirements.
In another embodiment, one or more compliant acoustic solid
material ring seals, comprising an elastomer of about 3 to 55
durometer (Shore A), are preferably easily replaced by the hearing
professional. This is necessary for both clinical reasons and for
the resulting wear that will occur. This is caused by the many
insertions and removals of the instrument from the ear canal.
In another embodiment, one or more compliant acoustic solid
material ring seals, comprising an elastomer of about 3 to 55
durometer (Shore A), are preferably securely held and positioned on
the hearing aid body by two close tolerance annular channels and by
the elastic tension of the elastomer ring seals when assembled on
the annular channels.
In yet another embodiment, one or more compliant acoustic solid
material ring seals, comprising an elastomer of about 3 to 55
durometer (Shore A), are made from one or more soft, compliant
materials. By way of illustration, some suitable compliant
materials include silicone polymer, polyurethane and polymeric
retarded recovery foam.
In another embodiment, one or more compliant acoustic solid
material ring seals, comprising an elastomer of about 3 to 55
durometer (Shore A), have one or more different cross-sectional
shapes. One preferred cross section is a quad type of seal with
four lobes. This provides twice the acoustic sealing surface of a
comparable standard circular cross section.
In another embodiment, one or more compliant acoustic solid
material ring seals, comprising an elastomer of about 3 to 55
durometer (Shore A), have different combinations of cross sectional
shapes on the same hearing aid body. The system can thus be finely
tuned to the patient's special requirements.
In another embodiment, one or more compliant acoustic solid
material ring seals, comprising an elastomer of about 3 to 55
durometer (Shore A), provide acoustic seals near the transmitter
and near the receiver and face plate. The result is reduced power
required for the transmitter and improved battery life.
In another embodiment, one or more compliant acoustic solid
material ring seals, comprising an elastomer of about 3 to 55
durometer (Shore A), provide controlled vibration isolation of the
hearing aid positioned in the ear canal This lowers the natural
frequency of the hearing aid positioned in the ear canal.
SUMMARY OF THE INVENTION
In accordance with one aspect of this invention, there is provided
a hearing aid assembly comprising a hearing aid, wherein said
hearing aid is comprised of an acoustic receiver, an acoustic
transmitter, a body, a first annular channel, and a first annular
ring with a cross-sectional T shape. In one preferred embodiment,
(a) the acoustic receiver is operatively configured to fit into an
external acoustic meatus of an ear, (b) the acoustic transmitter is
operatively configured to fit into an inner ear canal of said ear,
(c) the body is disposed between said acoustic receiver and said
acoustic transmitter, said body being generally elliptical, (d) the
first annular channel is disposed on a surface of said body such
that said first annular channel circumscribes said body's
circumference, (e) the first annular ring is disposed within said
first annular channel, (f) the first annular channel has a first
depth which is less than a depth of said first annular ring, such
that said first annular ring protrudes from said first annular
channel, (g) the quotient of a depth of said first annular channel
divided by a thickness of said first annular ring is less than
about 0.85, (h) the body further comprises a first cavity and a
second cavity, each of which extends through a surface of said
body, and (h) the first annular ring comprises a noncircular cross
section with at least five sides.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be described by reference to the following
drawings, in which like numerals refer to like elements, and in
which:
FIG. 1 is a sectional view of an ear;
FIG. 2 is a sectional view of the ear of FIG. 1 showing one hearing
aid of the present invention;
FIG. 3 is a sectional view of the ear of FIG. 1 showing a different
hearing aid of the present invention;
FIG. 4 is a schematic view of one hearing aid of the present
invention;
FIG. 5 is a schematic view of another hearing aid of the present
invention;
FIG. 6 is a schematic diagram of a computer aided manufacturing
process for use in the production of one embodiment of the present
invention;
FIG. 7 is an isometric view of one preferred embodiment of the
invention;
FIGS. 8A, 8B, and 8C are sectional views of some preferred seal
assemblies of the present invention; and
FIG. 9A is top view of another embodiment; and
FIG. 9B is a sectional view of another embodiment.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
FIG. 1 is a sectional view of an ear 10 of a human being. This
sectional view of the ear 10 is taken from "The Anatomy Chart
Series," Classic Library Edition, ISBN 0-9603730-4-7, Lb. Cat No.
86-071078, Page 21. In the embodiment depicted, the ear 10 is a
right ear.
Reference also may be had, e.g. FIG. 1 of U.S. Pat. No. 6,228,020,
which is ". . . a sectional elevational view of a user's hearing
area to show the anatomy thereof." The entire disclosure of such
United States patent is hereby incorporated by reference into this
specification.
FIG. 2 is a sectional view of the ear 10 with a hearing aid
assembly 12 disposed within the ear canal channel 14. The hearing
aid assembly 12 is comprised of a first seal 16 that is disposed
just prior to the bony portion 18 of the ear. In the embodiment
depicted, the bony portion 18 starts at point 20. The distance
between the end 22 of the first seal 16 and the point 20 is
preferably no greater than about 2 millimeters and, more
preferably, is from about 0.5 to about 2 millimeters. This distance
will vary with each patient's unique anatomy. In one preferred
embodiment, such first seal 16 has a cross-sectional shape in the
form of a T.
In this specification, reference will be made to both "seal 16" and
"ring 16," and also to both "seal 24" and "ring 24." As will be
apparent to those skilled in the art, the elements 16 and 24 are
seals that, in one embodiment, may be ring shaped; and the term
"seal" and "ring," as used with respect to these elements, denotes
the same thing.
Referring again to FIG. 2, and in the preferred embodiment depicted
therein, it will be seen that the hearing aid assembly is comprised
of a second seal 24 that is comprised of a front surface 26. The
surface 26 is located prior to the beginning point 28 of the
Temporalis muscle 30. In one aspect of this embodiment, the surface
26 is no more than about 2 millimeters from point 28 and, more
preferably, is from about 1 to about 2 millimeters from about point
28. Again, this precise distance will vary with the unique anatomy
of each individual patient. In one embodiment, such second seal 24
has a cross-sectional shape in the form of a T.
FIG. 3 depicts the assembly 12 located in the ear 10. FIG. 3
differs from FIG. 2 in that the seal 16 is located past (and not
prior to) the beginning point 20 of bony section 18. In the
embodiment, the front face 21 of the seal 16 is at least about 1
millimeter past the point 20 at which the bony section 18 of ear 10
begins. The precise distance by which the assembly 12 protrudes
into the bony section will vary with the anatomy of the
patient.
Referring again to FIG. 3, and in the embodiment depicted, it will
be seen that hearing aid assembly 12 is comprised of a transmitter
32. As is known to those skilled in the art, hearing aid
transmitter assemblies are often comprised of amplifiers, speakers,
signal processing circuitry, and other electronic components.
Reference may be had, e.g., to U.S. Pat. No. 5,048,090 (hearing aid
with transmitter and microphone housing parts), U.S. Pat. No.
5,835,610 (hearing aid system), U.S. Pat. Nos. 4,061,972, 6,229,900
(hearing aid including a programmable processor), U.S. Pat. No.
5,338,287 (electromagnetic induction hearing aid device), U.S. Pat.
No. 5,447,489 (bone conduction hearing aid device), U.S. Pat. No.
5,202,927 (remote controllable, programmable hearing aid system),
U.S. Pat. No. 4,947,432 (programmable hearing aid), and the like.
The entire disclosure of each of these United States patents is
hereby incorporated by reference into this specification.
FIG. 4 is a sectional view of one preferred hearing aid assembly 12
comprised of annular rings 16 and 24. Referring to the embodiment
depicted, the annular rings 16 and 24 are preferably comprised of
an elastomeric material with certain properties.
The annular rings 16/24 preferably have a hardness, as measured by
Shore A Durometer readings, of from about 8 to about 85. In one
embodiment, the Shore A hardness is from about 10 to 15 and, more
preferably, 12 to 14.
Elastomeric materials with these hardness ratings are well known.
Thus, silicone rubber often has a hardness of from about 10 to
about 60. By way of illustration, one suitable material is, e.g.,
DYNA FLEX TPE, a thermoplastic elastomeric material with a shore
hardness of about 13 that is sold as product number G67713.
These and similar elastomeric materials are commercially available.
Thus, by way of illustration and not limitation, one may use one or
more of the medical grade elastomeric materials available from the
Nusil Technology Company of 1050 Cindy Lane, Carpniteria,
Calif.
In one embodiment, it is preferred that the annular rings 16/24
have a tensile strength of form about at least about 400 pounds per
square inch. In one embodiment, the tensile strength of the annular
rings 16/24 is at least about 450 pounds per square inch and may
range from about 450 to about 2,000 pounds per square inch. In one
embodiment, the tensile strength is from about 500 to about 700
pounds per square inch. In another embodiment, the tensile strength
is from about 600 to about 1,750 pounds per square inch.
The elongation of the annular rings 16/24 preferably ranges from
about 40 to 125 percent, and, in one embodiment, is from about 50
to 90 percent.
In one embodiment, the annular rings 16 and 24 comprise or consist
essentially of a thermoplastic polyurethane elastomer such as,
e.g., "PELLETHANE 2363-80A," sold by the Dow Plastics Group of the
Dow Chemical Company. Polyurethane elastomers are preferred in that
they have good blood and tissue compatibility.
In one embodiment, the annular rings 16/24 are comprised of the
polymeric material disclosed in U.S. Pat. No. 5,002,151, the entire
disclosure of which is hereby incorporated by reference into this
specification.
In one embodiment, the hardness of the annular ring 16 is lower
than the hardness of the annular ring 24. In one aspect of this
embodiment, the ratio of the hardness of the annular ring 16 to the
hardness of the annular ring 24 is less than about 0.9 and,
preferably, less than about 0.7. In one embodiment, such ratio is
less than about 0.6. It is preferred, however, that the annular
rings 16/24 each have a hardness that is at least about 8 Shore A
hardness
Referring again to FIG. 4, and to the preferred embodiment depicted
therein, it will be seen that annular rings 16/24 are each disposed
within grooves 17/25. These grooves 17/25 preferably have a depth
50 that is less than the thickness of the annular rings 16/24. This
is best illustrated with reference to FIG. 8A.
Referring to FIG. 8A, and in the preferred embodiment depicted
therein, it will be seen that annular groove 17 has disposed within
it annular ring 52 that extends beyond the top 54 of the annular
groove 17 by a distance 56 so that the annular ring 52 may engage
in a compression fit with the ear canal of a patient. Thus, the
height 58 of the annular groove 17 (see FIG. 8C) divided by the
height 60 of the annular ring 16 is preferably less than about 0.85
and, even more preferably, less than 0.8. In one embodiment, such
ratio is less than about 0.75.
Referring again to FIGS. 8A, 8B, and 8C, it is preferred that the
annular rings 16/24 have cross-sectional shapes such that, in the
absence of any compression, they are removably and lockably engaged
within their corresponding annular grooves 17 and 25.
One means of obtaining this removable locking engagement is shown
in FIGS. 8A, 8B, and 8C. Thus, in the embodiments depicted, in FIG.
8A, the four lobed quad is one preferred cross section of the
compliant acoustic solid ring seals. It provides twice the sealing
surface of the comparable o-ring and because of this double sealing
action less pressure is required to maintain an effective acoustic
seal. The seal is held firmly in the channel by the additional
material in the channel that conforms the four lobed quad.
In FIG. 8B, the o-ring cross section of the compliant acoustic
solid ring seals is shown. The seal is held firmly in the channel
by the additional material in the channel near the outer surface of
the hearing aid body.
In FIG. 8C, the mushroom type cross section of the compliant
acoustic solid ring seals is shown. The seal is held firmly in the
channel by the additional material in the channel near the base of
channel.
What each of the embodiments of FIGS. 8A, 8B, and 8C have in common
is that the annular ring used has a cross-sectional shape that
contains more than 5 sides. As will be apparent, the circular
cross-sectional shape has an infinite number of sides, and the
other cross-sectional shapes have more sides than is conventionally
found with a rectilinear cross-sectional shape.
As is known to those skilled in the art, annular rings with shapes
similar to those depicted in FIGS. 8A, 8B, and 8C are commercially
available. Thus, by way of illustration, Minnesota Rubber pioneered
the design and production of four-lobed seals with the "QUAD RING"
design.
Referring again to FIGS. 8A, 8B, and 8C, in addition to having
cross-sectional shapes of the annular rings 16/24 that contribute
to them being lockably engaged within the grooves 17/25, the
grooves 17/25 also may have cross-sectional shapes that contribute
to such locking engagement. Thus, and referring to FIG. 8A, it will
be seen that groove 17, especially in its upstanding walls, has a
cross-sectional shape that engages the indented portions of the
acoustic seal.
Referring again to FIG. 4, and to the preferred embodiment depicted
therein, it will be seen that hearing aid assembly 12 is comprised
of a body 13 that, in the area between annular seals 16 and 24, is
recessed with somewhat concave shape. Consequently, and referring
to FIG. 3, when the hearing aid assembly is disposed within a
patient's ear canal, the area of the body 13 between the annular
seals 16 and 24 will not be contiguous with the Temporalis muscle.
As is known, the Temporalis muscle moves when a patient opens his
mouth, moves his jaw, and/or moves his head; and it is preferred
that such movement not cause contact between such muscle and the
body 13 of the hearing aid assembly.
Referring again to FIG. 4, and in the embodiment depicted, the
shaded areas 60 and 62 represent the recesses required for a
particular patient to avoid contact of his Temporalis muscle with
the body 13.
FIG. 5 illustrates a configuration of a hearing aid assembly 12
that may be used in the manner depicted in FIG. 2, wherein the
annular seal ring 16 is disposed in front of bony portion 18, which
starts at point 20. By comparison, FIG. 5 illustrates a hearing aid
assembly 12 that may be used in the manner depicted in FIG. 3,
wherein the annular ring 16 is disposed behind the point 20. As
will be apparent, the distances between the annular rings 16 and 24
vary in the embodiments of FIGS. 4 and 5.
FIG. 6 is a schematic diagram of a preferred computer aided
manufacturing process 70 required to economically produce the
preferred hearing aid 12. Two ear impressions (72/74) of the
patient are taken but not limited to just two, since unusual
clinical situations may require additional ear impressions. The
first ear impression 72 is a standard type, while the second 74 is
taken of the ear canal when the geometry is modified by
temporomandibular joint action and changes in head position. The
ear impressions are scanned using the three dimensional scanner A
three dimensional virtual image is created with computer aided
design of each ear impression. The images are compared and examined
for areas where material should be removed or added resulting from
temporomandibular joint action and changes in head position.
Material is removed in the critical area between the two compliant
acoustic solid material ring seals such that the hearing aid is
positioned and held in alignment by the two acoustic ring seals
16/24. No hearing aid acrylic shell body material is in contact
with the ear canal between the two compliant acoustic solid
material ring seals 16/24. The acoustic ring seal seating channel
depth is preferably maintained at a constant distance from the
patient's ear canal. This insures a uniform peripheral contact
pressure of the compliant acoustic solid material ring seals with
the ear canal. The completed shell date is then imported to the 3D
printing equipment. 80. The printers use stereo lithography that
preferably uses a laser to solidify thin layers of a hypoallergenic
UV cured acrylic liquid polymer. The shell is manufactured by the
3D printer. The face plate and electronics assembly are mounted in
the shell. Compliant acoustic solid ring seals are mounted into the
seal channels.
The process illustrated in FIG. 6 may be performed, e.g., by well
known prior art means. Thus, for example, one may use the
techniques described in published United States patent application
US 2002/0138237, the entire disclosure of which is hereby
incorporated by reference into this specification. Relevant
portions of this published patent application are presented
below.
"Various methods of determining or acquiring the shape of a body,
such as an ear impression, are well-known in the art. Determination
of position of a point on a surface of an object may be performed
by moving a mechanical device into contact with the point and
reading the position of the mechanical device, e.g. using a
co-ordinate measuring machine having scales on moving parts."
"In non-contact measurements, positions of points on the surface of
an object may be determined by transmitting one or more beams of
radiated energy towards the object and detecting radiated energy
that has interacted with arbitrary parts of the object."
"The shape of an object may also be determined with a plurality of
electronic cameras. The object is then illuminated by a set of
incoherent light sources, such as light bulbs, emitting
substantially white light in all directions. A plurality of cameras
with known positions in relation to each other are used to
determine positions of points of the surfaces of the object by
triangulation methods."
"When the shape of the auditory canal is acquired by scanning of
the canal itself, dynamic recording of the auditory canal may be
performed. Since the shape of the auditory canal changes as a
result of speaking, eating, drinking etc, this method of acquiring
the shape of the auditory canal provides data which vary in time
whereby such shape changes can also be taken into consideration
during manufacture of the corresponding hearing aid housing."
"Alternatively, a plurality of impressions may be made of the
auditory canal with the jaw in various respective positions in
order to accommodate shape changes of the auditory canal. For
example, two impressions may be made namely one with closed mouth
and one with open mouth."
"Having acquired digital data representing the shape of the
auditory canal and a part of the outer ear, these data may be
further manipulated according to well-known methods of CAD/CAM
systems to design and produce a hearing aid housing, e.g. including
forming a three-dimensional model of the shape of the hearing aid
shell. Further, the model may be displayed on a computer screen in
various three-dimensional views and two-dimensional cross-sections,
and various automatic and operator controlled functions, including
the functions described herein, for adjustment of the model may be
provided by a CAD/CAM system."
"Thus, according to the present invention, a CAD/CAM system is
provided for design and manufacture of a hearing aid housing with a
face plate and a shell that is matched to the auditory canal of a
user, comprising a processor that is adapted to receive and process
data representing the shape of the auditory canal, forming a
three-dimensional model of the shell based on the data, and
outputting data representing the model for production of the shell
and the face plate based on the model."
"Two identical models may be formed from the acquired digital data,
i.e. a model of the auditory canal including a part of the outer
ear, and a model of the hearing aid shell. The model of the
auditory canal remains unchanged while the model of the hearing aid
shell may be subject to modifications and additions of various
features as will be described below. The models may be displayed in
distinguishable colors, and the shell may be displayed inserted in
the auditory canal. For this and other purposes, the model of the
auditory canal may be displayed transparently."
"Upon formation of the three-dimensional model of the hearing aid
shell, a contour encircling the shell may be selected for
definition of a junction between the hearing aid shell and the face
plate, and data representing the selected junction contour may be
determined. Preferably, the junction contour is a plane
contour."
"According to the invention, the shell is produced based on the
model and may be terminated with an outward opening defined by the
junction contour. In one embodiment of the invention the junction
contour data are transferred to a numerically controlled machine
that automatically cuts a separately manufactured face plate along
a contour that matches the junction contour. As mentioned above,
the junction contour may be a plane contour compatible with a plane
face plate."
"According to a preferred embodiment of the invention, a
three-dimensional model of the face plate is formed that matches
the selected junction contour, and the face plate model and the
shell model are combined into one three-dimensional model of the
hearing aid housing. Based on the combined model, a hearing aid
housing with an integrated face plate is produced, e.g. utilizing a
rapid prototyping technique, such as stereolithography, laser
sintering, fused deposition modeling, drop deposition printing
(resembles ink jet printing), etc."
"Displaying the model of the hearing aid housing inserted in the
auditory canal model may facilitate selection of a position of the
acoustic output opening so that the output opening emits sound in
the direction of a longitudinal axis of the auditory canal thus,
minimizing the risk of the output opening emitting sound towards a
wall of the auditory canal or even being partially or entirely
occluded by an auditory canal wall."
"The outer dimensions of the hearing aid shell model may be
selectively increased so that the corresponding hearing aid shell
exerts a pressure on the auditory canal tissue when the shell is
inserted in the auditory canal. The outer dimensions may be
uniformly increased over the entire surface of the shell, or the
size increase may be reduced gradually along a longitudinal axis of
the shell so that very little or no pressure is exerted on tissue
residing deeply in the auditory canal. Alternatively or
additionally, the outer dimensions may be increased at selected
areas of the shell surface, e.g. forming a rib partly or fully
encircling the hearing aid shell, the rib providing a tight seal
against the auditory canal wall when the shell is inserted in the
auditory canal."
"Further, a tightening contour may be selected that extends along
the surface of the shell and partly or fully encircles the shell. A
groove extending along the contour may be included in the model
having a cross-section with a shape and dimensions that match a
desired tightening ring to be mounted in the produced shell, or
alternatively, that is adapted for automatic deposition of a
material different from the material of the shell, the deposited
material constituting a tightening protrusion. The tightening
protrusion or the tightening ring provides an appropriate and
secure tightening of the shell to the auditory canal when the shell
is mounted in the auditory canal. If the hearing aid does not
provide a good seal when inserted in the auditory canal, feedback
generating oscillations usually occurs and the gain has to be
decreased and thus, the full capabilities of the hearing aid can
not be utilized. Further, the shape of the auditory canal typically
changes in response to user activity, such as chewing, yawning,
etc. A rigid hearing aid shell may not be capable of adjusting to
changes in auditory canal shape due to movements of the jaw and
thus, a shell that is perfectly fitted initially may produce
unsatisfactory results in normal use. A flexible tightening ring
solves this problem."
"In an embodiment wherein the shape of the auditory canal has been
determined dynamically, the tightening contour is preferably
selected at positions corresponding to positions in the auditory
canal at which the above-mentioned dynamic variations of the
dimensions of the auditory canal exhibit small variations whereby a
secure and tight mounting of the shell in the auditory canal is
provided independent of user activity."
"Three-dimensional models of shapes and geometries of various
hearing aid components, such as microphones, signal processors,
output transducers, etc, may be stored in a database, and may be
selected for incorporation into the hearing aid. Utilizing
well-known CAD/CAM methods, models of the selected components may
be positioned and displayed within the hearing aid housing model
and may be moved around for selection of respective optimum
positions and orientations, e.g. for provision of a hearing aid of
a minimum size. Collision checks may be performed, and positions of
the features of the hearing aid shell, e.g. the vent channel, may
also be moved around to further optimize positioning of the hearing
aid components."
"Although there may be sufficient room for a specific component at
a certain position within the shell, it may not be possible to move
the component into that position, e.g. because the internal volume
of the shell forms a bottle neck at the input opening. Thus, during
design of the hearing aid, collision check may also be performed
during movement of the component in question through the input
opening into the shell along a desired path towards the desired
mounting position."
"The shape of the shell may be adjusted selectively in order to
increase the internal volume of the shell for provision of
sufficient space for a specific component. Preferably, the outer
volume of the shell is increased at areas corresponding to ear
locations that are relatively non-sensitive to pressure."
"The selection of the path of the junction contour may be performed
while the shell model is displayed as inserted in the auditory
canal. In this way, the position of the face plate covering the
shell outward opening may be selected for optimum cosmetic
appearance when the hearing aid is inserted in the auditory canal.
It should be noted that a model of a part of the outer ear should
be included in the model of auditory canal facilitating evaluation
of the cosmetic appearance of the hearing aid. Typically, an
impression of an auditory canal also contains an impression of a
part of the outer ear."
"The surface of the shell model may be smoothed to eliminate sharp
edges and comers and to obtain a smooth surface. The entire shell
may be smoothed or specific areas of the shell may be selected,
e.g. using a computer mouse with a cursor, for smoothing by well
known CAD/CAM smoothing techniques."
"For example, presence of cerumen or fall off tissue in the
auditory canal when the impression of the auditory canal is made
may create undesired artifacts in the shell model. An artifact may
be removed from the hearing aid housing model by deleting the
surface covered by the artifact from the model and calculating a
new surface substituting the deleted surface based on the model
surface surrounding the artifact."
"Further, a serial number or another identification of the produced
hearing aid housing may be incorporated into the housing model,
e.g. in a selected position, so that the housing may be produced
with an inherent identification."
"The finished hearing aid housing model may be stored in a database
for later retrieval. The database may be utilized for further
automation of the design process. For example, the acquired data
representing the shape of an auditory canal may be compared to the
shape of housing models stored in the data base, and the best match
may be retrieved and the positions of features of the hearing aid
housing and selections, positions, and orientations of hearing aid
components may automatically be reused in the hearing aid housing
to be designed. An operator may subsequently adjust or change the
retrieved positions, orientations and selections. The comparison
may be performed solely for selected corresponding areas of the
hearing aid housings. The models may be stored in the database in a
reduced form requiring a reduced amount of data, since the very
high mechanical tolerances required for production of hearing aid
housings are not required for comparisons of shape with the purpose
of reusing positions, orientations, selections, features, or
components relating to the stored hearing aid housing models."
"A patient database may be formed comprising records with a patient
identifier, e.g. name and number, holding the hearing aid housing
model of the patient in question. The records may further hold
respective models of the original impression of the auditory canal
of the patient, and identifiers and models of the hearing aid
components used in the patient's hearing aid, etc. A new hearing
aid for a specific user may then be produced without having to
acquire the shape of the auditory canal again, e.g. by making a new
impression of the auditory canal, since the previously acquired
shapes may be easily retrieved from the patient database."
"It is well-known in the art to produce a housing based on a
three-dimensional computer model of the housing utilizing so-called
rapid prototyping techniques, such as stereolithography, laser
sintering, fused deposition modeling, drop deposition printing,
etc. For example, in stereolithography, the computer model is
converted into a number of cross-sections that may be equidistant,
plane-parallel and horizontal, but need not be. Then, the housing
is manufactured by producing the individual cross-sectional planes
successively and on top of each other, underneath each other or
next to each other and joining them together. A container with
activated liquid synthetic resin may be located on a computer
controlled movable platform. By targeted use of radiation directed
at the surface of the liquid synthetic resin and causing at least
part-polymerization of the synthetic resin, it is possible to
generate a first cross-section of the hearing aid housing. After
completion of each cross-section, the platform is lowered by the
layer thickness so that the next cross-sectional plane on the
surface of the liquid synthetic resin can be produced in the same
way. This continues until the polymerized housing can be removed
from the container."
"Laser sintering is another layered fabrication process producing a
three-dimensional object from powdered materials in a layered
fashion utilizing heat generated by a CO2 laser. As in
stereolithography, the computer model is converted into a number of
cross-sections successively produced by applying the laser beam to
a thin layer of powder. The laser beam fuses the powder particles
to form a thin layer of solid mass. The laser sintering process
allows for the use of a variety of powdered materials."
"A further possibility is to produce the cross-sections with a
printing method similar to that used in an ink-jet printer, i.e. a
drop deposition printing, for example, by consecutively producing
successive cross-sections using the drop depositioning printing
and, after at least partial polymerization which should already
take place at the printing operation, by then stacking them on top
of each other and joining them to form a shell."
"It is an important advantage of the present invention that a
hearing aid housing that is matched to a specific auditory canal
and that includes various features, e.g. an integrated face plate,
a ventilation channel, a tightening protrusion, a battery opening
with engaging means, an ear wax guard holder, etc, can be produced
automatically with a minimum of manual operations."
"Preferably, the shell is produced from a flexible, sweat resistant
material. The material should not cause allergic reactions. The
shells are preferably polished in a polishing cylinder. The
material may be colorless or may be of a color that is close to a
desired color. Then, the shell may be colored in a coloring
substance of a desired color, e.g. by dipping the shell in the
coloring substance."
FIG. 7 is an isometric view of one preferred embodiment of the
invention.
FIG. 9A is a top view of one preferred seal 16 of the invention,
and FIG. 9B is a sectional view of seal of FIG. 9A, taken along
lines 9B-9B. Referring to FIGS. 9A and 9B, it will be seen that
seal 16 is comprised of an orifice 100 and, disposed around such
orifice 100, a base 102 and upstanding sections 104 and 106. As
will be apparent, section 106 cannot readily be seen in FIG. 9A but
is depicted in FIG. 9B.
In the preferred embodiment depicted in FIGS. 9A and 9B, it is
preferred that upstanding sections 104 and 106 each have a wall
thickness 108 of at least about 0.039 inches.
In the preferred embodiment depicted in FIGS. 9A and 9B, it is also
preferred that the base 102 have a wall thickness 110 of at least
about 0.031 inches, provided that the wall thickness 108 divided by
the wall thickness 110 is at least 1.1 and, more preferably, at
least about 1.26.
In the preferred embodiment depicted in FIGS. 9A and 9B, it is
preferred that the seal 16 have a Shore A hardness of from about 12
to about 14 and that it has an elongation of from about 40 to 80
percent.
* * * * *